Regulatory Affairs Manager
Regulatory Affairs Manager Software as a Medical Device (SaMD)
Location : Germany (Remote)
I am currently seeking an experienced Regulatory Affairs Manager who holds experience with SaMD or SiMD.
- Regulatory Strategy : Develop and implement strategies for SaMD compliance.
- Submissions : Prepare and manage European regulatory submissions
- Compliance : Ensure ongoing compliance with FDA, EMA, and other regulations.
- Documentation : Maintain regulatory documentation and reports.
- Collaboration : Work with engineering, quality, and product teams to integrate regulatory requirements.
- Regulatory Intelligence : Stay updated on regulatory changes and communicate updates.
- Training : Provide regulatory training and support to internal teams.
Qualifications :
- Bachelor's degree; advanced degree preferred.
- Experience in regulatory affairs for SaMD or SiMD products.
- Knowledge of global regulatory requirements. Also hold strong technical knowledge of IEC 62304 and ISO 27001 standards
- Strong documentation, communication, and project management skills.
- Detail-oriented with analytical and problem-solving abilities.
If you are interested in continuing your journey in SaMD please click apply as i would love to speak with you about this exceptional company.
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